Country preparedness for the introduction and appropriate use of antibiotics: operational guidance

Overview

WHO’s Country preparedness for the introduction and appropriate use of antibiotics: operational guidance (“operational guidance”) provides a comprehensive framework for countries to use in planning for the introduction of an antibiotic into their health system. It is particularly focusing on "Watch" and "Reserve" antibiotics used to treat multidrug-resistant organisms, recognizing that these critical medications often face commercial and regulatory challenges that limit their availability.

The operational guidance outlines an approach to planning the introduction and implementation of these products, considering their unique characteristics and associated needs. It emphasizes the need for evidence-based planning and coordination, particularly in low- and middle-income countries where access to newer antibiotics remains limited despite a high burden of drug-resistant infections. This operational guidance serves as a practical tool for various stakeholders including country-level decision-makers, regulatory authorities, healthcare professionals, and program managers for developing detailed, costed plans for antibiotic introduction that integrate with existing national AMR strategies.

The framework covers the entire pharmaceutical value chain from decision-making and registration through to implementation, monitoring, and evaluation. This operational guidance has been developed as part of SECURE, an initiative led by WHO and the Global Antibiotic Research and Development Partnership (GARDP) aimed at improving antibiotic access.